Delaware | 000-55764 | 81-5333008 |
(State or other jurisdiction of incorporation) | (Commission File Number) | (I.R.S. Employer Identification No.) |
o | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
o | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
o | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
o | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Dated: May 15, 2018 | EXICURE, INC. | |
By: | /s/ David A. Giljohann, Ph.D. | |
Name: | David A. Giljohann, Ph.D. | |
Title: | Chief Executive Officer |
Exhibit 99.1 | |
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• | Launched Phase 1 clinical trial of AST-008, a TLR9 agonist for immuno-oncology applications. Received authorization from Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom to conduct a Phase 1 clinical trial of AST-008 in the United Kingdom and began dosing healthy subjects during the fourth quarter of 2017. Our current plan anticipates preparing and commencing a Phase 1b/2 clinical trial for AST-008 late this year. |
• | Began dosing patients in the Phase 1 clinical trial of XCUR17 in early April 2018. This trial is designed to test safety and efficacy of the drug. Twenty-five patients will be enrolled and dosed over a period of 26 days. We expect trial data during the third quarter of this year. |
• | Generated pre-clinical data utilizing an SNA designed to stimulate the production of SMN2 mRNA for application in spinal muscular atrophy (SMA). These data suggest that the SNA design may potentially have superior pharmacodynamics properties compared to other nucleic acid therapeutic designs. We are currently collecting in vivo data in SMA mouse models. |
• | Informed by our sponsoring market maker that FINRA has cleared our Form 211. This important step in our path toward trading on the OTCQB has been completed. We are now addressing final administrative items and expect to announce beginning of trading in the near future. |
• | Strengthened management team with the appointment of Matthias Schroff as Chief Operating Officer. Dr. Schroff brings to Exicure a proven track record in clinical development and deep experience in the immuno-oncology, RNAi and gene expression, and TLR9 biology. |
March 31, 2018 | December 31, 2017 | ||||||
ASSETS | |||||||
Current assets: | |||||||
Cash and cash equivalents | $ | 21,124 | $ | 25,764 | |||
Unbilled revenue receivable | 5 | 13 | |||||
Receivable from related party | 21 | 17 | |||||
Prepaid expenses and other assets | 1,897 | 1,844 | |||||
Total current assets | 23,047 | 27,638 | |||||
Property and equipment, net | 1,275 | 1,317 | |||||
Other noncurrent assets | 32 | 32 | |||||
Total assets | $ | 24,354 | $ | 28,987 | |||
LIABILITIES AND STOCKHOLDERS’ EQUITY | |||||||
Current liabilities: | |||||||
Current portion of long-term debt | $ | 776 | $ | — | |||
Accounts payable | 974 | 1,049 | |||||
Accrued expenses and other current liabilities | 1,265 | 1,273 | |||||
Current portion of deferred revenue | — | 1,034 | |||||
Total current liabilities | 3,015 | 3,356 | |||||
Long-term debt, net | 4,103 | 4,855 | |||||
Common stock warrant liability | 651 | 523 | |||||
Other noncurrent liabilities | 277 | 278 | |||||
Total liabilities | $ | 8,046 | $ | 9,012 | |||
Stockholders’ equity: | |||||||
Common stock, $0.0001 par value per share; 200,000,000 shares authorized, 39,454,821 issued and outstanding, March 31, 2018; 39,300,823 shares issued and outstanding, December 31, 2017 | 4 | 4 | |||||
Additional paid-in capital | 54,394 | 53,586 | |||||
Accumulated deficit | (38,090 | ) | (33,615 | ) | |||
Total stockholders' equity | 16,308 | 19,975 | |||||
Total liabilities and stockholders’ equity | $ | 24,354 | $ | 28,987 |
Three Months Ended, March 31, | |||||||
2018 | 2017 | ||||||
Revenue: | |||||||
Collaboration revenue | $ | 36 | $ | 2,432 | |||
Total revenue | 36 | 2,432 | |||||
Operating expenses: | |||||||
Research and development expense | 3,275 | 3,488 | |||||
General and administrative expense | 2,045 | 1,426 | |||||
Total operating expenses | 5,320 | 4,914 | |||||
Operating loss | (5,284 | ) | (2,482 | ) | |||
Other income (expense), net: | |||||||
Interest expense | (161 | ) | (204 | ) | |||
Other income (loss), net | (64 | ) | 34 | ||||
Total other income (loss), net | (225 | ) | (170 | ) | |||
Net loss | $ | (5,509 | ) | $ | (2,652 | ) | |
Basic and diluted loss per common share | $ | (0.14 | ) | $ | (15.62 | ) | |
Basic and diluted weighted-average common shares outstanding | 39,357,289 | 169,794 |
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